FDA/Tobacco

The thirty-year long struggle to tame the tobacco industry the opened a new phase last month when the Food and Drug Administration (FDA) said it would focus on “presence of nicotine in cigarettes in amounts associated with addiction.”

FDA chief, Dr. David Kessler, wrote the American Heart Association on February 25, 1994 to say that there is no exemption under the law for cigarettes. But he added, cigarette vendors have been given the benefit or the doubt that they intend for cigarettes to be smoked for “pleasure” and not for drug effects– ie. “to affect the structure or function of the body.” He added that “it has been well-known for many years that some people smoke for the drug effects of nicotine (for example, for stimula­tion and/or to satisfy a dependence on nicotine)….” What led to this statement is mounting evidence that cigarette manufacturers, in Kessler’s words, “may intend that their products con­tain nicotine to satisfy an addiction on the part of some of their customers.”

Nicotine is well known as being powerfully addictive. And cigarette makers control the levels of nicetine that they inject into their final product. Indeed, most smokers believe they are addicted to their smoking habit, according to a Canadian survey. Most or them desire to quit but say they are addicted.

For years cigarette technology has been available to control precisely the amount of nicotine in cigarettes. Tie manufacturers see their products as nicotine-delivery systems. In documents discovered during the Cipollone litigation against a cigarette company, a Philip Morris senior scientist, William L. Dunn, Jr., said as much, asserting: “No one has ever become a cigarette smoker by smoking cigarettes without nicotine.”

Anti-smoking groups have long suspected that cigarette makers use levels of nicotine to hook youngsters into the tobacco addiction. Some have even charged that companies “spike” the cigarettes they high­light to the younger smoker or smoker-to-be market.

Kessler made no such charge, being a cautious regulator. He did say that should the FDA compile q record that concludes that cigarette vendors are selling their product to satisfy a nicotine addiction, the agency would then have a legal basis for regulating nicotine in tobacco as a “drug” under existing law.

Such regulation could remove from the market any tobacco products that contain nicotine at levels that cause or satisfy addiction, wrote. Kessler quickly added that such a mote would have “dramatic effects on our society” and therefore he wants Congress to provide clear direction to the agency.”

There you have it. The nicotine issue has been joined. Kessler intends to compile the evidence for nicotine regulation and work with Congress “to resolve, once and for all, the regulatory status of cigarettes under the Food, Drug and Cosmetic Act. Few public health issues are more important,” he told the Heart Association.

Stay tuned. In the meantime, watch for tar and nicotine levels on your cigarettes, if you are a smoker. And write your member of Congress to find out what they think about Kessler’s direction.

Recent Posts